Speaker 1: From Bloomberg News and I Heart Radio. It's the big take.
Speaker 1: I'm Westcasova today a small lab in Connecticut that's finding
Speaker 1: toxins in medications and health products a lot of us use.
Speaker 1: I know that was kind of a tabloid teaser there
Speaker 1: at the top, but we've got a bit of an
Speaker 1: alarming story today. One of the jobs of the US
Speaker 1: Food and Drug Administration is to make sure that the
Speaker 1: medications and other health products like the odorant and sunscreen
Speaker 1: that we all use are safe, and for the most part,
Speaker 1: they do a pretty good job of it. But recently,
Speaker 1: an independent lab called valish Or has started doing its
Speaker 1: own testing of big brand name products, and they've turned
Speaker 1: up some concerning results. Zan Tech is a popular pill
Speaker 1: used to treat heartburg a new research that it could
Speaker 1: be linked to cancer as prompting retailers to pull it
Speaker 1: off their shelves. Johnson and Johnson voluntarily recalled a number
Speaker 1: of popular sunscreen brands after traces of a cancer causing
Speaker 1: chemical were found inside dry shampoo, but it's safety is
Speaker 1: being questioned yet again. The concern high levels of benzinge,
Speaker 1: a cancer causing chemical, detected Elevated levels of benzinge in
Speaker 1: a number of sanitizing products on the market. My colleague
Speaker 1: Anna Ednie joins me now she's a national healthcare reporter
Speaker 1: here in Washington and Ednie, thanks so much for coming
Speaker 1: on the show. Thanks for having me. Do you've written
Speaker 1: this really interesting story about a company that is testing
Speaker 1: some of the biggest, best known drugs a lot of
Speaker 1: us take them, uh and finding some dangerous stuff in there.
Speaker 1: Tell us about this company is called valascher Balasher is
Speaker 1: an analytical lab based in New Haven Kinnectic Hit and
Speaker 1: they started off back in as just away. They thought
Speaker 1: there was a gap in the market that you know,
Speaker 1: there wasn't a lot of oversight of drugs once they
Speaker 1: are out there and approved by the Food and Drug Administration,
Speaker 1: and you rely on the pharmaceutical companies to hopefully be
Speaker 1: doing some of this. But what they have found is
Speaker 1: they're not always testing for maybe some certain impurities or
Speaker 1: um some of the drugs might not be dissolving like
Speaker 1: they should be, and so they wanted to take a
Speaker 1: look at that. But their biggest findings that they've made
Speaker 1: in recent years was looking into dantach and they found
Speaker 1: a carcinogen that has abbreviated n d m A. I'm
Speaker 1: not going to try to say the full name on
Speaker 1: this podcast of that chemical, but it used to be
Speaker 1: used in rocket fuel, and so Zantac, of course, is
Speaker 1: one of the most used medications in the US. Remind
Speaker 1: people what it does. It's a heartburn medication among other things.
Speaker 1: You know, a lot of stomach issues that it can
Speaker 1: be used for um and they even give it to
Speaker 1: babies and a liquid form who you know have had
Speaker 1: upset stomach issues. And so it was one of the
Speaker 1: first blockbuster drugs. We define that as a drug that's
Speaker 1: sold more than one billion in sales. So it was
Speaker 1: approved in nineteen eighty three by the Food and Drug
Speaker 1: Administration and it was just extremely widely used for decades
Speaker 1: until Valisher came along and did some testing and found
Speaker 1: this n d m A in there. So vlischert tested
Speaker 1: Santech they found this d m A. What does n
Speaker 1: d m A do. It's what the World Health Organization
Speaker 1: calls a probable carcin engine. So the w h O
Speaker 1: ranks carcinogens things that can cause cancer and humans. And
Speaker 1: there are your definite carcinogens like A S. Festos and
Speaker 1: then a probable carcinogen is a chemical like n d
Speaker 1: m A, where it's shown to cause cancer in animals,
Speaker 1: but there just hasn't been human testing. And why was
Speaker 1: this substance in zanta It's an interesting case because Zantac
Speaker 1: was actually forming n d m A on its own,
Speaker 1: as it sits on a shelf that can form n
Speaker 1: d m A, and particularly in higher room temperatures, so
Speaker 1: you can think about like a delivery truck in the
Speaker 1: summer or your bathroom, um, where a lot of people
Speaker 1: store things in their medicine cabinet, is enough to cause
Speaker 1: the n d m A to form. It's a chemical
Speaker 1: reaction between some of the ingredients essentially and the manufacturing
Speaker 1: process that the Antach used. So this is an unforeseen
Speaker 1: consequence you by this stuff. It's completely fine to stick
Speaker 1: on the shelf, use it every now and then, and
Speaker 1: at some point some of it may develop this substance,
Speaker 1: which could potentially be pretty bad for you. That's exactly right.
Speaker 1: And um, you know, at this point, like Santac was
Speaker 1: made by many different companies, so it was widespread because
Speaker 1: the patent on Zantech expired and so generic makers were
Speaker 1: then allowed to make their own versions of the same drug.
Speaker 1: That's right. The generic companies were able to make what
Speaker 1: we call renitodine. It's the active ingredient in zantac, so
Speaker 1: they don't use necessarily the Zantac brand name. But the
Speaker 1: generic companies were making renitodine. But then the FDA stepped
Speaker 1: in and said, you couldn't make any of those versions
Speaker 1: with that ingredient, and so they pulled it and then
Speaker 1: reintroduced it with another ingredient that was safer. That's right.
Speaker 1: The f d A asked the companies to withdraw their
Speaker 1: zantac and renitodine, depending on which version they make, and
Speaker 1: now it is back on the market using a different
Speaker 1: ingredient from motadine, which is the same as in pepsid.
Speaker 1: PEP said, of course, another herdburn medication. That's pretty popular, right, Um,
Speaker 1: so valish your chok it upon itself to test this drug.
Speaker 1: Why why did they bother doing that? It goes back
Speaker 1: a little bit. So there was a drug, it's a
Speaker 1: heart medication called val sartin, and back in millions of
Speaker 1: these pills were recalled by the genera companies that make
Speaker 1: them and ones like them Low Sartain, Herbis Sartain, and
Speaker 1: they were recalled because n d M A, the chemical
Speaker 1: we've been talking about, was found in them. You know,
Speaker 1: just in the course of knowing that that happened, it
Speaker 1: was it was a huge recall, and no one had
Speaker 1: really taken it to the next step and tested the
Speaker 1: drug for it, and so they just decided to test
Speaker 1: the drug. Now, if there was all this scientific literature
Speaker 1: saying that there was a possible cercinage in in this
Speaker 1: big drug, why didn't the manufacturers tested themselves? That's a
Speaker 1: good question. It's been an interesting journey watching Vallisher do
Speaker 1: this and kind of seeing the company's respond and sometimes
Speaker 1: even seeing how the Food and Drug Administration responds. They
Speaker 1: often can be slow and with a regulatory agency, it's
Speaker 1: bureaucracy and red tape sometimes, and you know, we don't
Speaker 1: really get great answers from the drugmakers on why they
Speaker 1: wouldn't have already been testing for Was it difficult for
Speaker 1: valich or to find this? Is it a laborious testing process? No,
Speaker 1: I actually got to see this testing process. I visited
Speaker 1: their lab in Connecticut and it's a really big, expensive machine.
Speaker 1: I mean, you and I couldn't do it, but any
Speaker 1: drug maker has to have this machine because they're doing
Speaker 1: all kinds of tests on it's the gold standard for
Speaker 1: how you test things. But does the f d A
Speaker 1: actually do any testing of its own or is it
Speaker 1: relying completely on what the drug makers tell them about
Speaker 1: the drugs. The FDA does not do any testing on
Speaker 1: its own. They have to rely on what they're told
Speaker 1: about the drug. They try to their best to verify
Speaker 1: that the data is right and it's not manipulated in
Speaker 1: some way. They do very very very tiny, tiny amount
Speaker 1: of checking in on some of these products that are
Speaker 1: already on shelves. Do you think when a company like
Speaker 1: Valishort tests and finds a possible car sin gen in
Speaker 1: a very popular drug, the FDA would welcome that information,
Speaker 1: but you're reporting found different. A lot of people would
Speaker 1: and I would assume that the FDA would welcome that
Speaker 1: information is something that's helpful to them. But Lasher has
Speaker 1: done it, not just with Santac, but personal care products
Speaker 1: like sunscreen and anti perse brant as well. And the
Speaker 1: f d A really pushes back with Zantac. They pushed
Speaker 1: back pretty hard and you know, tried to be little
Speaker 1: Lasher's data. Why do you think they had such a
Speaker 1: negative reaction to a discovery that could possibly harm users
Speaker 1: of this drug. I think it's a really curious question.
Speaker 1: I've covered the FDA for a really long time now
Speaker 1: what I've seen with these kinds of situations, valischer Um
Speaker 1: is the biggest that it's happened to, But it has
Speaker 1: happened in the past where researchers have come forward with
Speaker 1: some disturbing findings about a drug and they've been fought
Speaker 1: most of the way, and so the reaction from the
Speaker 1: FDA just always seems to be defensive at first. I
Speaker 1: guess one question a lot of people might be thinking.
Speaker 1: I know I'm thinking it is the FDA just in
Speaker 1: the pocket of drug makers. Is that relationship where they're
Speaker 1: reliant on drug makers to give them all the data
Speaker 1: which then they approve or disapprove of create a power
Speaker 1: imbalance here? Yeah, I think it's a phrase I've heard
Speaker 1: a lot is regulatory capture in relation to the FDA,
Speaker 1: and what is that? What it means is is when
Speaker 1: an agency works really closely with an industry, and in
Speaker 1: this case, the they do with the drug makers um,
Speaker 1: and it's so close that it's eventually seems to turn
Speaker 1: a little bit and that the agency is working more
Speaker 1: for the industry rather than the people it's supposed to protect.
Speaker 1: And it's not necessarily nefarious or money exchanging hands or
Speaker 1: something like that, you know, behind closed doors, but just
Speaker 1: a cued outlook from being sort of isolated and dealing
Speaker 1: with the industry so much. And Ednie, thank you for
Speaker 1: joining me today. It was great to be on. Thanks West.
Speaker 1: We'll come back to this idea of whether the f
Speaker 1: d A is too close to drug companies in just
Speaker 1: a bit, but first I talked to the CEO of Avalisher,
Speaker 1: the lab that started all of this. I'm here with
Speaker 1: David Light, the CEO of Valicher, the company we've been
Speaker 1: talking about. And David, I want to start by asking
Speaker 1: you what made you think to even tests antech for carcinogen's. Yeah,
Speaker 1: so Valuscher actually started off commercially with its own pharmacy.
Speaker 1: So our pharmacy was our biggest client, and we would
Speaker 1: be testing every batch of every medication that we dispensed
Speaker 1: all over the United States. So Zantech was just part
Speaker 1: of our standard screening that we were doing at Valisher
Speaker 1: and back in two thousand nineteen when we owned the pharmacy,
Speaker 1: So it batches of zantech. I mean, you get, you know,
Speaker 1: hundreds of bottles of it coming on the shelf for
Speaker 1: the phremiacy, and you would test a certain amount of it, right,
Speaker 1: So what we would test is just a sample from
Speaker 1: a large batch. So for example, if we had ten
Speaker 1: thousand tablets that we would buy it from, our wholesaler,
Speaker 1: will take a few of those tablets, analyzed those before
Speaker 1: we dispense any further tablets from that batch. What happened
Speaker 1: actually with Zantex specifically, was we had just added our
Speaker 1: carcinogenic analysis screen where we were looking for probable human
Speaker 1: carcinogens like n d m A. And it was actually
Speaker 1: one of our co founders, his infant daughter was prescribed
Speaker 1: a syrup version of zantec or nittatin, and we put
Speaker 1: it through our system and we're chocked to find essentially
Speaker 1: what became the fundamental instability of the zantec molecule that
Speaker 1: was forming very high levels of n d m A.
Speaker 1: Once you discovered this, obviously a big deal, you want
Speaker 1: to let people know so that it doesn't continue to happen.
Speaker 1: What happened next? Who did you report it to? So
Speaker 1: we filed an FDA SISM petition with the FDA, and
Speaker 1: it was also picked up by a lot of press
Speaker 1: in including Bloomberg, and it was great to see that
Speaker 1: there was a lot of recognition of at least what
Speaker 1: we perceived as the problem back in September of two
Speaker 1: thousand nineteen, which was that there was a fundamental instability
Speaker 1: in the molecule. So in September there's also an announcement
Speaker 1: by the f d A and the e m A,
Speaker 1: the Upeans Medicines Agency that came out on renting products
Speaker 1: including Zantac, saying that there was a small level of
Speaker 1: n d m A detected as a contamination. And although
Speaker 1: that might be true and was shown to be true
Speaker 1: later on, we were much more concerned that it wasn't
Speaker 1: just a kind of batch to batch contamination manufacturing problem,
Speaker 1: but a fundamental problem with the drug itself that was
Speaker 1: not just being contaminated, it was actually forming the carcinogen
Speaker 1: and d m A. When you reported this, uh, how
Speaker 1: did the FDA respond? So they originally responded with that
Speaker 1: statement in September, you know, saying that this was kind
Speaker 1: of a small contamination problem, and six months later they
Speaker 1: actually did agree with our petition from the standpoint of
Speaker 1: withdrawing the drug entirely. So by April of theft, he
Speaker 1: withdrew all Rendine products from the market. Valoischer's kind of
Speaker 1: a loan in its field in doing this. If drug
Speaker 1: companies spent a whole lot of money testing their drugs
Speaker 1: for safety, and the FDA spends a lot of time
Speaker 1: scrutinizing it before they give it approval, why does your
Speaker 1: company need to exist? How is it that drugs are
Speaker 1: going out there with these flaws in them? So I
Speaker 1: think there's again a lot of misconceptions about what the
Speaker 1: f d A process is and how many facturers fit
Speaker 1: into that. But what stince on the market and being manufactured,
Speaker 1: it's really just the manufacturers producing those lots and those
Speaker 1: batches of the medication and then occasionally testing and then
Speaker 1: self reporting that data to the FDA. So the kind
Speaker 1: of consistency of manufacturing quality is very, very different than
Speaker 1: that original drug approval billion dollar process that a lot
Speaker 1: of people are familiar with as part of the FDA process.
Speaker 1: But once it's approved and on the market and that
Speaker 1: it's in manufacturing day to day, that there's a very
Speaker 1: different quality assurance world because the FDA relies on information
Speaker 1: from the drug companies and evaluating whether a medication is safe.
Speaker 1: Do you think that every drug as part of that
Speaker 1: approval process should go through an independent evaluation that that
Speaker 1: should have become a standard practice. Absolutely, And the FDA
Speaker 1: does have independent review boards for drug approval, but again
Speaker 1: they're just reviewing the data that was submitted to them
Speaker 1: by the manufacturers. So having as part of that independent
Speaker 1: review process an independent chemical analysis, not by a quote
Speaker 1: unquote third party laboratory, but by a private laboratory, I
Speaker 1: think is critically important. And the fact that Vlisher, a
Speaker 1: new and relatively small company, can have found so many
Speaker 1: of these problems in such a short period of time,
Speaker 1: I think it's fundamental proof that this is very much needed.
Speaker 1: And we're probably just scratching the surface. So let's sort
Speaker 1: of reception. Are you getting to your push to have
Speaker 1: independent labs evaluate the safety of drugs as part of
Speaker 1: the approval process. Do you think this is something that
Speaker 1: the FDA will embrace them? Are they going to go
Speaker 1: for that? So we're already seeing large players going for
Speaker 1: that from the manufacturing standpoint, from the purchaser standpoint, and
Speaker 1: there is precedent for this. Even from a regulatory perspective,
Speaker 1: you know, you can't buy electronics in the United States.
Speaker 1: You can't buy a lamp or a laptop adapter without
Speaker 1: it being independently tested. If you look at the badges
Speaker 1: that are on even your adapter, the CE mark, the
Speaker 1: U L mark, other marks that's actually required by regulation
Speaker 1: that those products need to be independently tested. If our
Speaker 1: lamps are independently tested, why not our pharmaceuticals. Given all
Speaker 1: the testing you've done on a wide variety of medications
Speaker 1: and just products, what percentage of things that we use
Speaker 1: sort of on our bodies, like sunscreen, anti pur sprints
Speaker 1: and medications have some sort of harmful ingredients in them
Speaker 1: that shouldn't be in there. Yeah, So it's a very
Speaker 1: broad question, and I can say that especially when we
Speaker 1: were operating our own pharmacy and we were looking very
Speaker 1: broadly in the pharmacy space, we were rejecting about ten
Speaker 1: percent of the batches of medications and consumer products that
Speaker 1: we were analyzing, and that could be for a carcinogenic contamination.
Speaker 1: That could be the dosage wasn't with inspect where the
Speaker 1: disillusion how the tablet actually dissolves was outside of our specifications,
Speaker 1: but there's certainly areas that have much higher percentages, Like
Speaker 1: mentioned sunscreen. We we did a deep dive study and
Speaker 1: found the citizen petition, and we were finding benzene, a
Speaker 1: known human carcinogen, in about of the sunscreen products that
Speaker 1: we analyzed. We did it also for body sprays and antipersprints,
Speaker 1: which are primarily aerosol cans, and we found about half
Speaker 1: of them were contaminated with benzine. And most recently, dry
Speaker 1: shampoo's a cosmetic product but often available in pharmacies. We
Speaker 1: found about seventy of those were contaminated with benzine. So
Speaker 1: given all that, how concerned should people be that the
Speaker 1: stuff they pick up of the pharmacy shelf is safe?
Speaker 1: It definitely adds a layer of concern that I think
Speaker 1: is very important to understand that we do need more
Speaker 1: of this independent review. These are very serious and real problems.
Speaker 1: When you see these large recalls that often follow it
Speaker 1: underscores that this isn't just an area of general concern.
Speaker 1: You know, there are other chemicals like DP, a pair
Speaker 1: of bins, others that people hear about, especially in the
Speaker 1: consumer space, that wererant further study that are active areas
Speaker 1: of scientists conducting research. But when we look at something
Speaker 1: like benzene is a completely different ballpark. It's practically a
Speaker 1: different planet. I mean, this is a molecule that has
Speaker 1: been studied for over a hundred years. There's dozens of
Speaker 1: epidemiological studies that have directly linked the exposure to benzene
Speaker 1: and increased risk of cancers in human beings, not just
Speaker 1: in animal studies, but in humans. So these are extremely
Speaker 1: concerning compounds that absolutely shouldn't be there. That Day itself,
Speaker 1: specifically on benzine, says that these are unacceptably toxic, should
Speaker 1: not be used in any pharmaceutical manufacturing whatsoever. Not just
Speaker 1: the drug substance, but even the inactive ingredients that go
Speaker 1: into a product should not contain benzene. Then why is
Speaker 1: benzine in products? Well, it obviously shouldn't be. You're never
Speaker 1: gonna find it on a product label. Um, it's not
Speaker 1: gonna say that it has benzine in there. And the
Speaker 1: reason that it's obviously there, as we've detected in multiple areas,
Speaker 1: is because independent testing doesn't exist in this world, and
Speaker 1: so it's probably assumed not to be there. It's it's
Speaker 1: been banned for decades, and it got into the supply chain,
Speaker 1: likely through the raw materials. Many companies have now pointed
Speaker 1: to the propellants through when you're spraying it, the thing
Speaker 1: that shoots it out of the can, right, what you're
Speaker 1: actually spraying shooting out of the can. The propellants like
Speaker 1: propane and butane are petroleum discialists that come out of
Speaker 1: the ground and it is often contaminated with benzine and
Speaker 1: is supposed to be refined out, but apparently hasn't been
Speaker 1: and we were able to detect that at Valisher and
Speaker 1: I think it's actually a great example of how vulnerable
Speaker 1: the supply chain is and this problem wasn't detected anywhere
Speaker 1: along that entire chain and likely for decades. David Light,
Speaker 1: thanks so much for taking the time to talk to me.
Speaker 1: Thanks so much for your interest in this. I really
Speaker 1: appreciate it. We asked the f d A if someone
Speaker 1: could come on the show. They declined. When I come back,
Speaker 1: more on that complicated, some say too close relationship between
Speaker 1: the FDA and the drug companies it overseas. I'm here
Speaker 1: with Dr Diana Zuckerman, the president of the National Center
Speaker 1: for Health Research and Washington d C. Dr Zuckerman, thanks
Speaker 1: for being here, my pleasure. Can you tell us first
Speaker 1: just what is the National Center for Health Research? What
Speaker 1: do you do? We're a nonprofit think tank. We focus
Speaker 1: on the safety and effectiveness of medical products and consumer products,
Speaker 1: and we don't take funding from any of the companies
Speaker 1: that make the products that we have valuate. Well, that
Speaker 1: is exactly what we're talking about here today. This testing
Speaker 1: lab vallisur has found harmful substances and potentially harmful substances
Speaker 1: in medications and other products that people use. In your
Speaker 1: own research, how common is that? Well, we don't know.
Speaker 1: I mean, that's the truth. I mean what we look
Speaker 1: at at our center is what data are available, what
Speaker 1: research is available, and sometimes there's no research available. So
Speaker 1: what values SHURE is doing is very important. And let
Speaker 1: me say, I don't know them. I've never talked to
Speaker 1: people there, we have no relationship. But it seems that
Speaker 1: what they're doing is analyzing the safety of products in
Speaker 1: a way that nobody else is doing and that the
Speaker 1: FDA is not doing so. Specifically with regard to the
Speaker 1: f d A, can you talk about why it is
Speaker 1: that the FDA that pharmaceutical manufacturers are not catching these
Speaker 1: ingredients when Valisher's lab has been able to detect them
Speaker 1: with sophisticated but not really very difficult or uncommon means.
Speaker 1: What we're seeing with some of these products, whether it's
Speaker 1: benzene or or other chemicals, what we're seeing is that
Speaker 1: in some cases these chemicals are part of the process
Speaker 1: of manufacturing. It's not noticeable. And of course, a carcinogen
Speaker 1: doesn't cause cancer tomorrow, you know, it takes years. Even
Speaker 1: if a carcinogen becomes present as part of the manufacturing process,
Speaker 1: there would not be a way for the FDA to
Speaker 1: know if it was at a level that was dangerous
Speaker 1: except years later, and that's it's too late by that.
Speaker 1: How did it come to be that the agency overseeing
Speaker 1: the safety of these products rely on the reporting of
Speaker 1: the manufacturer instead of doing independent testing themselves. The law
Speaker 1: that created the FDA is about a hundred years old.
Speaker 1: It's changed a little bit, not that much. You know,
Speaker 1: the FDA was a small, underfunded agency. They didn't have
Speaker 1: the money to do the studies. So the companies did
Speaker 1: the studies, and the FDA does vet the studies. They
Speaker 1: look at the research results. Sometimes they disagree completely with
Speaker 1: what the company says about the implications of the research results.
Speaker 1: But there is an honor system, and the honor system
Speaker 1: is that the FDA believes that the data that the
Speaker 1: company is providing, the raw data, are accurate, and they
Speaker 1: don't check those, and there are certain other things that
Speaker 1: they don't check. And of course there's so many products
Speaker 1: that it would be enormously expensive for the federal government
Speaker 1: to pay for all of it. Do you think that
Speaker 1: that is going to change now that we're starting to
Speaker 1: see an increase in the discovery of harmful substances in products.
Speaker 1: It sounds like the f d A hasn't been very
Speaker 1: enthusiastic about the value SURE analyzes, which I think is disappointing,
Speaker 1: and I'd like to know why that is. Why do
Speaker 1: you think that is As somebody who spends a lot
Speaker 1: of time looking at the f d A, why do
Speaker 1: you think that would be. There's always going to be
Speaker 1: a certain amount of resistance to change at the f
Speaker 1: d A, And really they don't want more work to
Speaker 1: do now you would think therefore they would welcome somebody
Speaker 1: else doing the work if they can't do it, but
Speaker 1: they'll still have to check it, you know, So it's
Speaker 1: not like it's completely done by somebody else. So what
Speaker 1: you're describing isn't necessarily a situation where the FDA has
Speaker 1: fallen down on the job. It's just that the resources
Speaker 1: they have and the rules that they work under don't
Speaker 1: actually allow for this kind of comprehensive testing. That's a
Speaker 1: great question, and I'm not sure that the law doesn't
Speaker 1: allow for it, but the law doesn't require it. And
Speaker 1: what happens that the f d A is if the
Speaker 1: law doesn't require it, there are a lot of things
Speaker 1: they're not going to do because they don't have enough
Speaker 1: staff and they don't have enough for sources, but also
Speaker 1: because that's not the way it's been done in the past.
Speaker 1: The FDA has always been the gold standard in certification
Speaker 1: for the safety of products. I think most Americans probably
Speaker 1: see that the FDA proved it, they feel pretty good
Speaker 1: about that. Should that be the case, should people have
Speaker 1: the kind of trust in the f d A that
Speaker 1: a lot of people do. The f d A has
Speaker 1: been the gold standard in many ways. It still is
Speaker 1: the gold standard, but there has been so much pressure
Speaker 1: from Congress and from industry to rush approvals that I know,
Speaker 1: for myself, i'd like to see a product that's been
Speaker 1: on the market for a while before I think it's
Speaker 1: really proven to be safe, because too many products are
Speaker 1: getting approved so quickly on the basis of short term studies. So,
Speaker 1: for example, if you study how safe is a product
Speaker 1: over three months, but most people take it for ten
Speaker 1: years or twenty years, you have no idea what that
Speaker 1: impact is going to be on those patients. Has the
Speaker 1: amount of time the FDA now takes to approve drugs
Speaker 1: and other products gotten shorter over the years. Absolutely, FDA
Speaker 1: used to be criticized for taking longer to get products
Speaker 1: on the market than most European countries. Now they're at
Speaker 1: least as fast getting it on the market. But you know,
Speaker 1: there's a difference because when a product gets on the
Speaker 1: market in the UK, for example, the National Health Plan
Speaker 1: won't pay for it until the evidence is clear, whereas
Speaker 1: in the United States, the FDA approves it, Medicare will
Speaker 1: pay for it, Medicaid will pay for it, insurance companies
Speaker 1: will pay for it, and there's not that gatekeeper to
Speaker 1: make sure that this really is a product that's better
Speaker 1: than other products. So to some all this up for us,
Speaker 1: how should people understand the relationship between the f d
Speaker 1: A and Farmer. Is it that it's too cozy or
Speaker 1: is it that the f d A is too understaffed,
Speaker 1: has too much work to do the testing that we need.
Speaker 1: I'd have to say all of the above, but the
Speaker 1: relationship is too cozy. And part of the reason why
Speaker 1: it's too cozy is because there are what are called
Speaker 1: user fees, where the companies are giving so much money
Speaker 1: to the f d A and having so many meetings
Speaker 1: with FDA staff that it becomes a much cozier relationship,
Speaker 1: much more difficult to have that tougher regulatory overview of
Speaker 1: a product and of what a company is doing. Dr
Speaker 1: Diana Zuckerman, thanks so much for joining me today. Thank you.
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